Industry Can Do More To Facilitate Approval Efficiency – CSDD
This article was originally published in Pharmaceutical Approvals Monthly
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Cutting non-core procedures – such as those supporting exploratory endpoints – from study budgets could save the industry $6 billion a year in drug development costs, the Tufts Center for the Study of Drug Development suggests in its 2013 industry outlook report.
The new molecular entity and novel biologic class of 2011 isn’t just the largest since 2004 – CDER also posted near-perfect on-time review performance while maintaining healthy rates of first-cycle approvals and a low 15 month average time to approval, thanks to a high level of innovation in the novel product candidates.
FDA’s Oct. 24 public meeting on the renewal of its drug user fee program demonstrated just how strong a position the agency is in regarding the renewal of the Rx part of the “UFA” legislation – most of the complaints were semantic, quite literally.